BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 20075806 · Received August 27, 2024

    Report

    Report Number
    1710034-2024-00940
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 5, 2024
    Report Date
    October 3, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903814343
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381434 AND LOT NUMBER 4070003. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    CORRECTION: INVESTIGATION CODES POPULATED. SUMMARY SUBMITTED WITH INITIAL MDR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT COMPLETELY RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO INCIDENTS WHERE THE NURSE HIT THE RETRACT BUTTON AND THE NEEDLE DID NOT RETRACT ALL THE WAY INTO THE PLASTIC AND REMAINED APPROX. 1/4¿ OUT. UNKNOWN DATES NO PATIENT HARM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953863 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4070003 00382903814343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown